Info Service on Health Issues (Apr19/04)
Geneva, 16 April (TWN): A medicines patent database set up by transnational originator pharmaceutical companies with the involvement of the World Intellectual Property Organization (WIPO) has come under criticism by the generic industry.
The International Generic and Biosimilar Medicines Association (IGBA), an international association of generic medicine manufacturers has called for the reassessment of WIPO’s involvement in the Patent Information Initiative for Medicines (Pat-INFORMED), a database of patent status of medicines.
Pat-INFORMED was launched in September 2018 as a partnership between WIPO and the International Federation of Pharmaceutical Manufacturing Associations (IFPMA), an international associations of pharmaceutical TNCs. It provides patent information on small molecule products in oncology, hepatitis C, cardiovascular, HIV, diabetes and respiratory therapy areas as well as any medicine on WHO’s Essential Medicines List which do not fall into the above therapeutic categories.
IGBA expressed their concern in a letter to WIPO Director-General Dr. Francis Gurry dated 6th February 2019. The letter says: “Given the many issues the IGBA has identified with respect to its potential impact on pharmaceutical competition, procurement and public health, we believe WIPO should reassess its involvement in this initiative and whether the inclusion of a link to the database on its website is appropriate for a United Nations agency”.
The letter expresses concerns “that (Pat-INFORMED) could unnecessarily delay patient access to more affordable medicines”. The letter contains three concrete concerns with regard to Pat INFORMED viz. patent linkage, lack of a verification mechanism to ensure accuracy of information, and the propriety of a UN agency to be part of such an initiative.
Patent Linkage: According to the letter “Pat-INFORMED is an inappropriate tool for medicines procurement. A database that purports to link patents with procurement serves as a tool for patent linkage.” This concern is raised in the light of the projection of Pat-INFORMED as a database to help procurement agencies. The press release announcing the launch of the Pat-INFORMED described it as “an online tool designed to help procurement agencies better understand the global patent status of medicines.”
IGBA raised doubts about the accuracy of information and states: “There may be a long list of irrelevant patents in the Pat-INFOMRED database that may easily mislead procurement agencies and unduly delay access to generic and biosimilar medicines, providing a disservice to public health.”
[There are often multiple patents granted on a medicine, depending on the patentability criteria of a country. Many of these patents can be “weak” or “trivial” thus not meeting the criteria of novelty or inventive step. When challenged, such patents could be revoked. By listing all patents over a medicine, Pat-INFORMED could create confusion and misperception resulting in delays in market entry of generic and biosimilar medicines.]
Accuracy of Information: A second concern is the lack of mechanism to verify the information directly uploaded by the originator companies in the database. According to the letter, “incorrect information can easily be uploaded to the database, and outdated information may not be revised or removed in a timely manner. This could easily mislead public authorities and delay the opportunity for generic medicines to participate in competitive tenders.”
The letter cites the example of the Orange Book of the United States Food and Drug Administration’ (FDA) which provides a mechanism for verification of patent listings. IGBA states that: “the FDA has established a way to referee disputes regarding the accuracy of listings in the Orange Book, and such listings by originator drug companies are made under penalty of federal law which includes criminal liability for providing false information to the U.S. government.”
The letter also recalls an earlier meeting with WIPO staff in October 2018 where IGBA had pointed out a mistake in the database with regard to Truvada (emtricitabine), whereby “on 18 September 2018, the UK Supplementary Protection Certificate (SPC/GB05/041) was invalidated with no possibility of appeal by Mr. Justice Arnold of the UK Court”.
Propriety of engagement: The letter points out the inappropriateness of WIPO as a UN agency to be part of an initiative which can prevent competition in the pharmaceutical market. It states: “the hosting of the Pat-INFORMED database on the WIPO website provides the public with the perception that WIPO and the United Nations more broadly views the information as being accurate and useful, even though the Pat-INFORMED database can easily be transformed by originator companies into a tool for anti-competitive delays for generic medicines access world wide as well as for bio similar medicines, in the event that larger molecules are added to the database in the future”.
Third World Network also expressed the concern on the adverse impact of Pat-INFORMED on procurement agencies. A report published on 5 October 2017 on the occasion of the soft launch of the Pat INFORMED stated:
“National or international procurement agencies may be intimidated by the existence of multiple patents and may choose to be cautious and avoid procuring generic medicines which may not even infringe the patents listed” (https://www.twn.my/title2/intellectual_property/info.service/2017/ip171003.htm). +